Downstream processing remains a major bottleneck for vaccine production, and the industry is racing to develop new purification technologies. Here's a snapshot of where we stand and of what needs to happen next to increase quality and yields.
- The Global Market Landscape For Peptide Drug Conjugates
- A Short Guide On Transitioning From Monoclonal Antibody To AAV Separation Science
- The Clinical Landscape Of ADCs In 2023: Diverse Technologies, Narrow Target
- Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi
- Women Rising In Biotech
- Best Practices For Cell Culture Media Fingerprinting
- Add Efficiency From Development To Validation With Design Of Experiments
A Short Guide On Transitioning From Monoclonal Antibody To AAV Separation Science
Separation scientists jumping from mAbs to AAV inherently have advantages, but familiarity can also present roadblocks. Here are a few tips on leveraging past experience with mAbs when developing AAV gene therapy products.
The Clinical Landscape Of ADCs In 2023: Diverse Technologies, Narrow Target
Antibody-drug conjugates (ADCs) are a type of targeted cancer therapy that combines the specificity of monoclonal antibodies with the potency of cytotoxic drugs. This article shares data surrounding the ADCs currently entering clinical trials, a look at failed ADC programs, and more.
Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi
It can be difficult for broad biological compound claims to meet the two requirements in patent law that are used to “police” claim scope: the enablement requirement and the written description requirement. This article discusses the future of these types of patent claims after two Federal Circuit cases, Amgen v. Sanofi and Juno v. Kite.
Best Practices For Cell Culture Media Fingerprinting
This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available.
Add Efficiency From Development To Validation With Design Of Experiments
A statistically-based design of experiments shortens development timelines while reducing product development and validation costs. This works by shrinking the total number of experiments required to evaluate parameters while strengthening analysis.
Dispelling 4 Common Myths Of Data Quality Governance
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
Tackling Safety Issues Of Adjuvanted Vaccines
An adjuvant is a substance added to some vaccines to enhance the immune response and/or to reduce the number of doses required to achieve a protective effect. This article discusses the emerging use of adjuvants and assessing safety issues.
Draft FDA Labeling Guidance Proposes More Clarity For Providers
The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape.
PHARMA OUTSOURCING WHITE PAPERS
The Science Of Cell Therapy Thawing
A summary of the science of thawing following conventional slow freezing methods, the physical and biological implications of key metrics and components, and key studies from scientific literature.
Single-Use Solutions For Research And Process Development
Can supply chain assurance be maintained while offering an array of possibilities to achieve complex process designs? Learn if you could benefit from a modularized, standardized single-use manifold design.
Key Stages In mRNA-Based Therapeutic Development
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
Nanosuspension Dosage Forms: Product Development & Scale Up
For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.
Data Utilization For Advanced Analytics And Near Real-Time Monitoring
Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.
Advancing Drug Development Using In Silico Modeling
Learn how in silico modeling can improve the likelihood of clinical success and return on investment for investigational new drug development.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- 3 Steps To Optimize The Fed-Batch Process For mAb Production
- Biotech Enables Accelerated Scale-Up Of A Spray-Drying Program
- Process Development For AAV Vector Production In Suspension Cells
- Application Of A Sf-Rhabdovirus-Negative Platform For AAV Production
- What’s Happening In Cell & Gene Therapy Development?
The “Outsourcing Master Class” is a capstone-case-review, team-based course sanctioned by the International Association of Outsourcing Professionals (IAOP). Designed by Darren Dasburg, Chief Business Officer, CRISPR Biotech, these time-tested outsourcing fundamentals offer you a blueprint to keep teams working together on both sides.More Content Collections